BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1220298 · Received November 3, 2008

    Report

    Report Number
    1823260-2008-08132
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 10, 2008
    Report Date
    November 3, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 315 MG/DL AND 106 MG/DL WITHIN 10 MINUTES ON THE AVIVA SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR HUMALOG - 25 UNITS 3/DAY - 5 YEARS| LANTUS - 48 UNITS - 5 YEARS